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Terminated

Spider Flex Monopolar Hook (Spider Surgical Instruments), TransEnterix, Inc., Durham, NC

FDA Recall Z-2465-2010 · Posted 2010-09-22

Recalling FirmTransenterix, INC
Recall StatusTerminated
Product CodeGCJ
Date Initiated2010-06-22
Date Terminated2011-01-31
Product Quantity46 boxes (6 units per box)

Reason for Recall

The hook end effecter from a monopolar device may become dislodged and fall into the patient when in use during laproscopic surgery. Retrieval from the patient may involve extended anesthesia time.

Firm Action

TransEnterix issued a "Field Action" letter dated June 22, 2010 to consignees, identifying the affected product and actions to be taken by the customer. Customers were instructed to return the product to TransEnterix, Inc. using the address label and return information provided. The firm will replace the product at no charge. TransEnterix Customer Care can be contacted at 1-888-879-4111.

Root Cause

Other

Distribution Pattern

Nationwide Distribution in the states of AZ, FL, GA, NC, NY, OH, OR, SC and TX.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K091697SPIDER SURGICAL INSTRUMENTS, MODELS 90004, 90005, 90007, 90009, 90010, 90012, 90013, 90015Transenterix, Inc. · 2009-09-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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